FDA.reportPublic FDA data

Eko Devices, Inc.

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CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response Pink - The CORE 500 Digital Stethoscope is intended to be used by clinicians to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician).The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data.

Eko Devices, Inc.

2026-04-03

CORE 500 Digital Stethoscope FIGS Earpiece - Orange Taffy - The CORE 500 Digital Stethoscope is intended to be used by clinicians to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician).The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data.

Eko Devices, Inc.

2026-04-03

CORE 500 Digital Stethoscope - Rose Gold Chestpiece - The CORE 500 Digital Stethoscope is intended to be used by clinicians to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician).The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data.

Eko Devices, Inc.

2026-04-03

CORE 500 Digital Stethoscope - Rose Gold Earpiece - The CORE 500 Digital Stethoscope is intended to be used by clinicians to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician).The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data.

Eko Devices, Inc.

2026-04-03

CORE 500 Digital Stethoscope - Bundle-ROG - The CORE 500 Digital Stethoscope is intended to be used by clinicians to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician).The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data.

Eko Devices, Inc.

2026-04-03

CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean Blue - The CORE 500™ Digital Stethoscope is intended to be used by clinicians or lay users to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500™ Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician or by lay users).A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional.

Eko Devices, Inc.

2026-01-29

EFAST (Eko Foundation Analysis Software with Transformers) - The Eko Foundation Analysis Software with Transformers (EFAST) is intended to support healthcare professionals in the evaluation of patients’ heart sounds and electrocardiograms (ECGs). The software calculates heart rate, detects the presence of murmurs associated with Structural Heart Disease, and determines murmur timing including the timing of S1, S2 heart sounds. When ECG is available, the software detects the presence of atrial fibrillation and normal sinus rhythm. The software is intended for use by or under the supervision of a healthcare professional and is not to be used as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the software are designed to support and not replace the healthcare professional’s clinical judgment. The murmur detection is intended for use on both pediatric and adult patients, while the detection of atrial fibrillation is intended for use on adults (> 18 years).

Eko Devices, Inc.

2026-01-29

ELEFT (Eko Low Ejection Fraction Tool) - Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure. This population includes, but is not limited to, patients with: coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity.

Eko Devices, Inc.

2025-03-17

Eko Analysis Software - The Eko Analysis Software is intended to provide support to the physician in the evaluation of patients' heart soundsand ECG’s. The software analyzes simultaneous ECG and heart sounds. The software will detect the presence ofsuspected murmurs in the heart sounds. The software also detects the presence of atrial fibrillation and normalsinus rhythm from the ECG signal. In addition, it calculates certain cardiac time intervals such as heart rate, QRSduration and EMAT. The software does not distinguish between different kinds of murmurs and does not identifyother arrhythmias.It is not intended as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the softwareare only significant when used in conjunction with physician over-read and is for use on adults (> 18 years)

Eko Devices, Inc.

2020-09-08

CORE 500 Digital Stethoscope - Cool Blue Chestpiece - The CORE 500 Digital Stethoscope is intended to be used by clinicians or lay users to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician or by lay users).A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional.

Eko Devices, Inc.

2025-11-07

CORE 500 Digital Stethoscope - Cool Blue Earpiece - The CORE 500 Digital Stethoscope is intended to be used by clinicians or lay users to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician or by lay users).A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional.

Eko Devices, Inc.

2025-11-07

CORE 500 Digital Stethoscope - Ruby Chestpiece - The CORE 500™ Digital Stethoscope is intended to be used by clinicians or lay users to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500™ Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician or by lay users).A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional.

Eko Devices, Inc.

2025-10-15

CORE 500 Digital Stethoscope FIGS Earpiece - Elderberry - The CORE 500™ Digital Stethoscope is intended to be used by clinicians or lay users to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500™ Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician or by lay users).A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional.

Eko Devices, Inc.

2025-10-15

CORE 500 Digital Stethoscope FIGS Earpiece - Off White - The CORE 500™ Digital Stethoscope is intended to be used by clinicians or lay users to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500™ Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician or by lay users).A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional.

Eko Devices, Inc.

2025-10-15

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